A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System

August 13, 2013 updated by: Ellipse Technologies, Inc.

A Retrospective Multicenter Review of Early Onset Spinal Deformity Patients That Underwent Either a Primary or Revision Spinal Bracing Procedure With the Ellipse Technologies MAGEC Spinal Bracing and Distraction System

The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11559
        • University of Cairo Public Hospital
  • Finland
      • Helsinki, Finland, 00029
        • University of Helsinki
      • Turku, Finland
        • Turku University Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • University of Hong Kong
  • Italy
      • Bologna, Italy
        • Instituto Rizzoli
      • Rome, Italy
        • Bambin Gesù
  • New Zealand
      • Auckland, New Zealand
        • Starship Children's Hospital
  • Turkey
      • Ankara, Turkey
        • Hacettepe University Hospital
      • Ankara, Turkey
        • Ankara Gazi Universitesi Hastanesi
      • Istanbul, Turkey, 34403
        • Florence Nightingale Hospital Ortopedi Bolumu
      • Istanbul, Turkey
        • Marmara Üniversitesi Eğt.ve Arş.Hastanesi
      • Izmir, Turkey
        • Ege Sağlık Hastanesi
  • United Kingdom
      • Cardiff, United Kingdom, CF 14 4XW
        • University Hospital of Wales
      • London, United Kingdom
        • The Harley Street Clinic
    • Middlesex
      • Stanmore, Middlesex, United Kingdom, HA7 4LP
        • Royal National Orthopaedic Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients worldwide implanted with the Ellipse Technologies Spinal Bracing and Distraction System (Invitation to Volunteer Non-Probability Sample).

Description

Inclusion Criteria:

  • Early onset spinal deformity with any etiology
  • Cobb angle measurement of 30 degrees or greater at the time of primary surgery
  • Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery
  • Age less than 11 years old at the time of MAGEC implant
  • Implanted with the MAGEC system as either a primary or secondary revision spinal bracing procedure
  • Patient has been implanted for a minimum of 6 months
  • Patient signs informed consent for the use of their personal private data

Exclusion Criteria:

  • Patient declines to sign informed consent for the use of their personal private data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
MAGEC Implant
All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Cobb Angle
Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in Degrees
Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Thoracic Spine Height
Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in millimeters (mm)
Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Space Available for Lung
Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured as a percentage (%)
Baseline and 6, 12, 18 and 24 Months Postoperatively
Ocurrence of Procedure-Related Complications
Time Frame: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Adverse Events
Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Baseline and 6, 12, 18 and 24 Months Postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Coronal Balance
Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in millimeters (mm)
Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Sagittal Balance
Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in millimeters (mm)
Baseline and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Subsequent surgical interventions following initial implantation
Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Weight
Time Frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in kilograms (kg)
Baseline and 6, 12, 18 and 24 Months Postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ellipse Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Behrooz A Akbarnia, MD, San Diego Center for Spinal Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR0056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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